Randi M. Germaine, M.D.; Revocation of Registration, 51665-51668 [E7-17757]
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Federal Register / Vol. 72, No. 174 / Monday, September 10, 2007 / Notices
Drug
Schedule
Methamphetamine (1105) ............
Amobarbital (2125) .......................
Pentobarbital (2270) .....................
Secobarbital (2315) ......................
Cocaine (9041) .............................
Oxycodone (9143) ........................
Hydromorphone (9150) ................
Diphenoxylate (9170) ...................
Meperidine (9230) ........................
Oxymorphone (9652) ...................
Sufentanil (9740) ..........................
Fentanyl (9801) ............................
II
II
II
II
II
II
II
II
II
II
II
II
The company plans on manufacturing
the listed controlled substances in bulk
for sale to its customers.
No comments or objections have been
received. DEA has considered the
factors in 21 U.S.C. 823(a) and
determined that the registration of Cody
Laboratories, Inc. to manufacture the
listed basic class of controlled substance
is consistent with the public interest at
this time. DEA has investigated Cody
Laboratories, Inc. to ensure that the
company’s registration is consistent
with the public interest. The
investigation has included inspection
and testing of the company’s physical
security systems, verification of the
company’s compliance with state and
local laws, and a review of the
company’s background and history.
Therefore, pursuant to 21 U.S.C. 823,
and in accordance with 21 CFR 1301.33,
the above named company is granted
registration as a bulk manufacturer of
the basic classes of controlled
substances listed.
Dated: August 28, 2007.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration.
[FR Doc. E7–17767 Filed 9–7–07; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
ebenthall on PRODPC61 with NOTICES
Randi M. Germaine, M.D.; Revocation
of Registration
On December 14, 2006, the Deputy
Assistant Administrator, Office of
Diversion Control, issued an Order to
Show Cause to Randi M. Germaine,
M.D. (Respondent), of Casa Grande,
Arizona. The Show Cause Order
proposed the revocation of
Respondent’s DEA Certificate of
Registration, BG3717278, as a
practitioner, as well as the denial of any
pending applications for renewal or
modification of the registration, on the
ground that his continued registration is
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15:27 Sep 07, 2007
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inconsistent with the public interest.
Show Cause Order at 1.
The Show Cause Order specifically
alleged that during the execution of a
search warrant at the Morenci
Healthcare Center (Respondent’s former
employer), copies of patient charts were
obtained which were then sent to a
medical expert for review. Id. at 2. The
Show Cause Order alleged that the
expert had concluded that Respondent’s
‘‘prescribing practices concerning
controlled substances did not meet the
usual standard of care.’’ Id. Relatedly,
the Show Cause Order alleged that
background checks on some of
Respondent’s patients indicated that
they ‘‘were receiving excessive and
unnecessary amounts of controlled
substances,’’ that they were known to
law enforcement to be ‘‘drug abusers,’’
and that some of them had committed
controlled-substance offenses. Id.
Relatedly, the Show Cause Order
alleged that some of Respondent’s
patients ‘‘were known to area
pharmacists as ‘doctor shoppers’ and
‘chronic early refillers.’ ’’ Id. Moreover,
‘‘a number of [Respondent’s] patients
were family members receiving the
same prescriptions for controlled
substances.’’ Id.
The Show Cause Order further alleged
that the ‘‘autopsy reports for two of
[Respondent’s] patients * * * showed
[that] the cause of death [was] drug
overdoses resulting from controlled
substances prescribed by’’ Respondent.
Id. The Show Cause Order also alleged
that another of Respondent’s patients
had ‘‘died after obtaining invalid
prescriptions from [him] for controlled
substances.’’ Id.
On January 8, 2007, the Show Cause
Order, which also notified Respondent
of his right to a hearing, was served on
him as evidenced by the signed returnreceipt card. Because (1) More than
thirty days have passed since service of
the Show Cause Order, and (2)
Respondent did not timely request a
hearing, I conclude that Respondent has
waived his right to a hearing. See 21
CFR 1309.53(c). I therefore enter this
Final Order without a hearing based on
relevant material found in the
investigative file and make the
following findings.
Findings
Respondent is the holder of DEA
Certificate of Registration, BG3717278,
which authorizes him to handle
controlled substances as a practitioner
at the registered location of Harvest
Medical Clinic, Inc., 1856 E. Florence
Blvd., Casa Grande, Arizona.
Respondent’s registration does not
expire until September 30, 2008.
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On August 25, 2003, the Greenlee
County Sheriff’s Office contacted the
DEA Tucson Diversion Group regarding
Respondent’s termination from the
Morenci Healthcare Center based on the
allegation that he over-prescribed
narcotic controlled substances. The
Sheriff’s Office also informed DEA
Investigators that R.S., a thirty-one year
old male inmate at the county jail and
patient of Respondent, had died and
that the autopsy report had found both
methadone and benzodiazepines in his
blood. While the autopsy report noted
that the cause of death could not be
determined and that the ‘‘[t]oxicology
findings may be equivocal due to
decomposition,’’ R.S. was known to
local law enforcement as a drug abuser.
The Sheriff’s Office further related that
Respondent had prescribed methadone
(10 mg. tablets) for R.S. for back pain.
Subsequently, R.S.’s medical records
were sent to Ted Parran, M.D., a boardcertified internist and Associate Clinical
Professor of Medicine and Family
Medicine at the Case Western Reserve
University School of Medicine and
Director of its Addiction Fellowship
Programs.1 According to Dr. Parran’s
report (hereinafter, Expert Report), R.S.
died four days after Respondent started
him on methadone and ‘‘had
demonstrated much drug seeking
behavior over the past two years.’’
Expert Report at 2. Dr. Parran noted that
R.S. ‘‘had [a]n MRI scanning
demonstrating little pathology, had
longstanding complaints and office
behavior out of proportion to evidence
of illness, and [a history] of noncompliance with [physical therapy]
referrals.’’ Id. Dr. Parran further noted
that R.S. ‘‘had been pretty much off of
opioid analgesics (except for a few
Vicodin or Percocet) and in [j]ail for a
while when for some reason he was
started on [m]ethadone * * * on 5/30/
02.’’ Id. Dr. Parran concluded that
‘‘[t]his prescribing is difficult to
imagine, fails to meet usual standards of
care and concern when prescribing
controlled drugs, appears to be for other
than [a] legitimate medical purpose, and
appears to have played a direct role in
the patient’s death.’’ Id.
On or about May 31, 2003, D.K., a
twenty-five year old female and another
of Respondent’s patients, died of a drug
overdose. According to the toxicology
report, hydrocodone, oxycodone,
diazepam, and nordiazepam were
present in D.K.’s blood. Furthermore,
the examining pathologist found that
1 Dr. Parran has also performed research and
issued written educational materials on addiction
and controlled-substance prescribing. He has also
developed a remedial education course on
controlled-substance prescribing.
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Federal Register / Vol. 72, No. 174 / Monday, September 10, 2007 / Notices
ebenthall on PRODPC61 with NOTICES
D.K.’s death ‘‘is due to an acute
intoxication due to the combined effects
of multiple prescription medications
including hydrocodone and
oxycodone.’’
Upon review of D.K.’s chart, Dr.
Parran found ‘‘much evidence of out of
control behavior.’’ Expert Report at 5.
More specifically, Dr. Parran noted that
D.K. had lied about her ‘‘drug use’’; that
there was ‘‘[c]lear evidence’’ that on
three occasions D.K. was ‘‘Dr.
shopping’’ and that on four other
occasions she engaged in ‘‘scams’’ to
obtain additional drugs; that her
medical complaints bore ‘‘no
resemblance to the physical exam’’; that
there were ‘‘multiple multiple early
refill attempts’’; and that approximately
five months before her death, another
physician had diagnosed her with
bipolar disorder and determined that
she ‘‘need[ed] to be tapered off of all
controlled drugs.’’ Id. at 5–6.
Dr. Parran also noted another visit in
which Respondent had noted that D.K.
was ‘‘worried about Hep[atitis] C and
HIV * * * needle stick exposure—
sharing needles,’’ and that she needed a
urine drug screen. Id. at 5. Dr. Parran
observed that Respondent nonetheless
issued D.K. a prescription for Vicodin
for ‘‘acute pain and cough.’’ Id.
Dr. Parran also found that D.K. had
not been prescribed controlled
substances between January and May 9,
2003, the latter being the date when
Respondent ‘‘began the prescribing that
ultimately contributed to [D.K.’s]
death.’’ Id. at 6. Dr. Parran noted that
Respondent issued prescriptions to D.K.
on May 9, 2003 for 90 hydrocodone; on
May 20, 2003, for another 90
hydrocodone; and on May 27, 2003, for
40 Percocet (oxycodone).2 Id. On May
28, 2003, D.K. overdosed and died three
days later. Id. Based on his review, Dr.
Parran concluded that Respondent’s
prescribing of controlled substances
‘‘fails to meet usual standards of care,
appears to be for other than legitimate
medical purpose and appears to have
contributed directly to the patient’s
death.’’ Id.
On July 31, 2003, S.B., a fifty-six year
old female patient of Respondent, also
died of a drug overdose. The toxicology
report noted that propoxyphene,
norproxyphene, and nordiazaepam were
present in her blood; the pathologist
concluded that S.B.’s death was ‘‘due to
2 According to the investigative file, D.K.’s chart
contained a notation indicating that only her OB/
GYN, who was treating her for pain related to a
minor surgical procedure, could prescribe
controlled substances to her. D.K.’s OB/GYN further
told investigators that there was no medical reason
why D.K. should have been prescribed controlled
substances after April 30, 2003.
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an acute multidrug intoxication
including * * * Propoxyphene.’’
DEA investigators subsequently
determined that between August 5,
2002, and July 21, 2003, Respondent
prescribed for S.B. numerous controlled
substances. More specifically, he
prescribed 5520 propoxyphene
capsules, 1200 hydrocodone (7.5/500
mg.) tablets, 729 Oxycontin tablets in
various strengths, 21 flurazepam (both
15 mg. and 30 mg. strength) tablets, 150
lorazepam (1 mg.) tablets, 90 oxycodone
(5 mg.) tablets, and 10 Duragesic (75
mcg.) patches.
Dr. Parran’s review noted that S.B.
‘‘was a longstanding patient of the
Health Center, with many medical
problems including arthritis and
headaches, and with a warning note on
the front of the chart * * * to ‘avoid all
narcotics.’ ’’ Expert Report at 3. Dr.
Parran further found that ‘‘from the first
time [Respondent] saw this patient [he]
began adding controlled drugs’’
including Vicodin, Darvocet, Fiorinal,
Tussionex, Oxycontin, Darvon, Ativan
(lorazepam), and flurazepam. Id.
Dr. Parran further noted that
Respondent had engaged in ‘‘an
additional flurry of prescribing’’ during
the period of March and April 2003. Id.
Specifically, he noted that Respondent
prescribed Oxycontin (40 mg.) on March
20th, Darvocet on April 1st, Vicodin on
April 11th, multiple strengths of
Oxycontin on April 14th, Vicodin and
Oxycontin again on April 21st, and both
flurazepam with two refills and a
Duragesic (fentanyl) patch on April
28th. Id. Dr. Parran further found that
‘‘in a six month period [Respondent]
prescribed 3700 tablets of opioids and
additional benzodiazepines and
barbiturates.’’ Id. Dr. Parran concluded
that ‘‘[t]his escalating prescribing of
controlled drugs to a drug seeking
patient who was clearly out of control
with her use fails to meet usual
standards of care, appears to be for other
than [a] legitimate medical purpose and
appears to have contributed to the
patient’s death.’’3 Id.
Dr. Parran also reviewed
Respondent’s prescribing with respect
to a fourth patient, N.G. Between
October 31, 2002, and April 10, 2003,
3 Following the death of S.B., Respondent’s
former employer reported Respondent to the
Arizona Medical Board. The Board subsequently
concluded that Respondent had committed
unprofessional conduct under Ariz. Rev. Stat. § 32–
1401(27)(q). The Board ordered that Respondent be
issued a letter of reprimand for excessive
prescribing and be placed on probation. The
Board’s decision focused entirely on Respondent’s
treatment of S.B. and did not discuss his
prescribing practices with respect to any other
patient. See In re Randi M. Germaine, M.D. (Ariz.
Med. Bd. Aug. 12, 2005) (Case # MD–03–0897A).
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Respondent prescribed for N.G., 1418
methadone (10 mg.) tablets, 605
oxycodone (5 mg.) tablets, and 120
hydrocodone (7.5/750 mg.) tablets.
According to Dr. Parran, this ‘‘patient
demonstrated Dr. shopping behavior
over a long period of time.’’ Expert
Report at 4. Moreover, based on a
December 12, 2002 toxicology
screening, another physician at the
clinic had indicated that N.G. had
violated her controlled-substance
contract. Id. Respondent nonetheless
continued to prescribe controlled
substances to her. Id.
Dr. Parran further noted that N.G.’s
chart indicated that she had engaged in
several scams to obtain additional
controlled substances including going to
the emergency room, and claiming
either that she had run out early or that
her drugs had been stolen. Id. Moreover,
notwithstanding that her chart included:
(1) A pharmacy use printout showing
that N.G. was engaged in the
‘‘tremendous over-use of controlled
drugs,’’ (2) ‘‘an extensive note’’ from
another physician ‘‘indicating that she
should get no more controlled drugs
from the practice,’’ and (3) a March 2003
note from another clinic (that N.G. had
been referred to) which diagnosed her as
a drug abuser and recommended that
she be ‘‘wean[ed] off of narcotics,’’
Respondent continued to prescribe
controlled substances to her. Id. Indeed,
three days after N.G. had again gone to
the emergency room trying to get early
medications, Respondent again
prescribed controlled substances to
her.4 Id. According to Dr. Parran, ‘‘[t]his
continued prescribing of controlled
drugs to a patient who was noncompliant with the treatment plan and
clearly out of control with her use fails
to meet usual standards of care and
appears to be for other than [a]
legitimate medical purpose.’’ Id.
According to Dr. Parran, another of
Respondent’s patients (D.J.), had
‘‘demonstrated multiple behaviors that
alerted the practice to her problems
with controlled drugs including early
calls, early visits, claiming [she was
going] ‘out of town’ for early scripts’’
but ‘‘then keeping the original
appointments.’’ Id. at 7. Moreover,
notwithstanding that: (1) D.J. had
broken her controlled substance
contract; (2) that another physician had
recently indicated that D.J. should no
longer be prescribed controlled
substances; and (3) that Respondent had
himself indicated that D.J.’s toxicology
test results were abnormal, that she was
engaged in doctor shopping, and that
4 Eventually another physician terminated N.G.
from the clinic’s practice.
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controlled drugs should be
discontinued; two months later,
Respondent gave D.J. a prescription for
Vicodin. Id. at 7–8. Respondent then
proceeded to issue D.J. numerous other
prescriptions including several early
prescriptions and one based on her
representation that she was going out of
town. Id. at 8. According to Dr. Parran,
Respondent’s ‘‘continued prescribing of
controlled drugs to a patient who was
non-compliant and clearly out of control
with her use fails to meet usual
standards of care and appears to be for
other than [a] legitimate medical
purpose.’’’ Id.
Discussion
Section 304(a) of the Controlled
Substances Act provides that a
registration to ‘‘dispense a controlled
substance * * * may be suspended or
revoked by the Attorney General upon
a finding that the registrant * * * has
committed such acts as would render
his registration under section 823 of this
title inconsistent with the public
interest as determined under such
section.’’ 21 U.S.C. 824(a)(4). With
respect to a practitioner, the Act
requires the consideration of the
following factors in making the public
interest determination:
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(1) The recommendation of the appropriate
State licensing board or professional
disciplinary authority.
(2) The applicant’s experience in
dispensing * * * controlled substances.
(3) The applicant’s conviction record under
Federal or State laws relating to the
manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State,
Federal, or local laws relating to controlled
substances.
(5) Such other conduct which may threaten
the public health and safety.
Id.
‘‘[T]hese factors are * * * considered
in the disjunctive.’’ Robert A. Leslie,
M.D., 68 FR 15227, 15230 (2003). I ‘‘may
rely on any one or a combination of
factors, and may give each factor the
weight [I] deem[] appropriate in
determining whether a registration
should be revoked.’’ Id. Moreover, case
law establishes that I am ‘‘not required
to make findings as to all of the factors.’’
Hoxie v. DEA, 419 F.3d 477, 482 (6th
Cir. 2005); see also Morall v. DEA, 412
F.3d 165, 173–74 (D.C. Cir. 2005).
In this matter, I acknowledge that the
Arizona Medical Board has not revoked
Respondent’s state license. The Board’s
inquiry was, however, limited to
Respondent’s prescribing to a single
patient. Therefore, I decline to defer to
the Board’s decision and conclude that
Respondent’s experience in dispensing
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controlled substances and his record of
non-compliance with Federal law and
regulations demonstrate that his
continued registration is ‘‘inconsistent
with the public interest.’’ 21 U.S.C.
823(f).
Factors Two and Four—Respondent’s
Experience in Dispensing Controlled
Substances and Record of Compliance
With Applicable Laws Relating to
Controlled Substances
Under DEA regulations, a prescription
for a controlled substance is not
‘‘effective’’ unless it is ‘‘issued for a
legitimate medical purpose by an
individual practitioner acting in the
usual course of his professional
practice.’’ 21 CFR 1306.04(a). This
regulation further provides that ‘‘an
order purporting to be a prescription
issued not in the usual course of
professional treatment * * * is not a
prescription within the meaning and
intent of [21 U.S.C. 829] and * * * the
person issuing it, shall be subject to the
penalties provided for violations of the
provisions of law related to controlled
substances.’’ Id. As the Supreme Court
recently explained, ‘‘the prescription
requirement * * * ensures patients use
controlled substances under the
supervision of a doctor so as to prevent
addiction and recreational abuse. As a
corollary, [it] also bars doctors from
peddling to patients who crave the
drugs for those prohibited uses.’’
Gonzales v. Oregon, 126 S.Ct. 904, 925
(2006) (citing Moore, 423 U.S. 122, 135
(1975)).
As found above, Dr. Parran, an expert
on the prescribing of controlled
substances, reviewed the medical
records of patients treated by
Respondent including several who had
overdosed on controlled substances. Dr.
Parran specifically noted that
Respondent prescribed controlled
substances to patients notwithstanding
that they were engaged in drug-seeking
behaviors including doctor shopping
and various scams used to obtain
additional prescriptions.
Moreover, Dr. Parran found in
multiple instances that Respondent’s
prescriptions were not issued for a
legitimate medical purpose. With
respect to R.S., Dr. Parran found that
Respondent’s ‘‘prescribing is difficult to
imagine, * * * appears to be for other
than [a] legitimate medical purpose, and
appears to have played a direct role in
the patient’s death.’’ Expert Report at 2.
In regards to D.K., Dr. Parran noted
that she too was engaged in doctor
shopping and other scams such as early
refill attempts and medical complaints
that were not confirmed by a physical
exam. Moreover, her chart included a
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51667
notation that only her OB/GYN could
prescribe controlled substances for her;
her OB/GYN told investigators that after
April 30, 2003, there was no medical
reason why she should have been
prescribed controlled substances.
Nonetheless, on May 9 and 20, 2003,
Respondent prescribed for D.K. drugs
containing hydrocodone, and on May
27, 2003, Respondent prescribed
Percocet (oxycodone). D.K. overdosed
the next day. Based on his review, Dr.
Parran concluded that Respondent’s
prescribing of controlled substances for
D.K. ‘‘appears to be for other than [a]
legitimate medical purpose and appears
to have contributed directly to [her]
death.’’ Id. at 6.
S.B. was another patient of
Respondent who died of an overdose.
With respect to her, Dr. Parran found
that notwithstanding that her chart
included a warning note to ‘‘avoid all
narcotics,’’ Respondent prescribed
controlled drugs including various
opiates including Vicodin, Darvocet,
Tussionex, Oxycontin, and Darvon. In
addition, Respondent prescribed other
controlled substances including
benzodiazepines and barbiturates. Dr.
Parran further found that in a six month
period, Respondent prescribed 3,700
tablets of opioids (as well as drugs in
other categories of controlled
substances). Dr. Parran concluded that
‘‘[t]his escalating prescribing of
controlled drugs to a drug seeking
patient who was clearly out of control
with her use * * * appears to be for
other than [a] legitimate medical
purpose and appears to have
contributed to the patient’s death.’’ Id.
at 3.
In sum, Dr. Parran’s findings provide
ample support for the conclusion that
Respondent was not issuing
prescriptions for ‘‘a legitimate medical
purpose,’’ 21 CFR 1306.04(a), but rather,
was ‘‘peddling to patients who crave the
drugs for * * * prohibited uses.’’
Gonzales v. Oregon, 126 S.Ct. 904, 925
(2006) (citing Moore, 423 U.S. 122, 135
(1975)). Accordingly, I find that
Respondent’s experience in dispensing
controlled substances is characterized
by repeated violations of the CSA. I
therefore conclude that Respondent’s
continued registration is ‘‘inconsistent
with the public interest.’’ 21 U.S.C.
823(f). Moreover, I further find that the
public safety requires that this Order be
effective immediately. 21 CFR 1316.67.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) & 824(a), as well as
28 CFR 0.100(b) & 0.104, I hereby order
that DEA Certificate Registration,
BG3717278, issued to Randi M.
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Germaine, M.D., be, and it hereby is,
revoked. I further order that any
pending applications for renewal or
modification of his registration be, and
they hereby are, denied. This order is
effective immediately.
Dated: August 30, 2007.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E7–17757 Filed 9–7–07; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF LABOR
Employee Benefits Security
Administration
Proposed Exemptions; D–11318,
Barclays Global Investors, N.A., (BGI)
and Its Investment Advisory Affiliates,
Including Barclays Global Fund
Advisors (BGFA; Together, the
Applicants); and D–11420 BlackRock,
Inc. (Black Rock) and Merrill Lynch &
Co. (Merrill Lynch) (Collectively, the
Applicants)
Avenue, NW., Washington, DC 20210.
Attention: Application No. __, stated in
each Notice of Proposed Exemption.
Interested persons are also invited to
submit comments and/or hearing
requests to EBSA via e-mail or FAX.
Any such comments or requests should
be sent either by e-mail to:
moffitt.betty@dol.gov, or by FAX to
(202) 219–0204 by the end of the
scheduled comment period. The
applications for exemption and the
comments received will be available for
public inspection in the Public
Documents Room of the Employee
Benefits Security Administration, U.S.
Department of Labor, Room N–1513,
200 Constitution Avenue, NW.,
Washington, DC 20210.
Notice to Interested Persons
AGENCY:
SUMMARY: This document contains
notices of pendency before the
Department of Labor (the Department) of
proposed exemptions from certain of the
prohibited transaction restrictions of the
Employee Retirement Income Security
Act of 1974 (ERISA or the Act) and/or
the Internal Revenue Code of 1986 (the
Code).
Notice of the proposed exemptions
will be provided to all interested
persons in the manner agreed upon by
the applicant and the Department
within 15 days of the date of publication
in the Federal Register. Such notice
shall include a copy of the notice of
proposed exemption as published in the
Federal Register and shall inform
interested persons of their right to
comment and to request a hearing
(where appropriate).
SUPPLEMENTARY INFORMATION:
ebenthall on PRODPC61 with NOTICES
Employee Benefits Security
Administration, Labor.
ACTION: Notice of proposed exemptions.
Written Comments and Hearing
Requests
All interested persons are invited to
submit written comments or requests for
a hearing on the pending exemptions,
unless otherwise stated in the Notice of
Proposed Exemption, within 45 days
from the date of publication of this
Federal Register Notice. Comments and
requests for a hearing should state: (1)
The name, address, and telephone
number of the person making the
comment or request, and (2) the nature
of the person’s interest in the exemption
and the manner in which the person
would be adversely affected by the
exemption. A request for a hearing must
also state the issues to be addressed and
include a general description of the
evidence to be presented at the hearing.
ADDRESSES: All written comments and
requests for a hearing (at least three
copies) should be sent to the Employee
Benefits Security Administration
(EBSA), Office of Exemption
Determinations, Room N–5700, U.S.
Department of Labor, 200 Constitution
VerDate Aug<31>2005
15:27 Sep 07, 2007
Jkt 211001
The
proposed exemptions were requested in
applications filed pursuant to section
408(a) of the Act and/or section
4975(c)(2) of the Code, and in
accordance with procedures set forth in
29 CFR part 2570, subpart B (55 FR
32836, 32847, August 10, 1990).
Effective December 31, 1978, section
102 of Reorganization Plan No. 4 of
1978, 5 U.S.C. App. 1 (1996), transferred
the authority of the Secretary of the
Treasury to issue exemptions of the type
requested to the Secretary of Labor.
Therefore, these notices of proposed
exemption are issued solely by the
Department.
The applications contain
representations with regard to the
proposed exemptions which are
summarized below. Interested persons
are referred to the applications on file
with the Department for a complete
statement of the facts and
representations.
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Barclays Global Investors, N.A., (BGI)
and Its Investment Advisory Affiliates,
Including Barclays Global Fund
Advisors (BGFA; Together, the
Applicants), Located in San Francisco,
California
[Application No. D–11318]
Proposed Exemption
The Department is considering
granting an exemption under the
authority of section 408(a) of the Act
and section 4975(c)(2) of the Code and
in accordance with the procedures set
forth in 29 CFR 2570, subpart B (55 FR
32836, 32847, August 10, 1990).
Section I. Transactions Involving OpenEnd Management Investment
Companies Other Than ExchangeTraded Funds
Effective as of September 10, 2007,
the restrictions of sections 406(a) and (b)
of the Act, section 8477(c)(1) and (c)(2)
of FERSA, and the taxes imposed by
section 4975(a) and (b) of the Code, by
reason of section 4975(c)(1)(A) through
(F) of the Code, shall not apply to the
acquisition, sale or exchange by an
Account of shares, including through inkind redemptions of shares or
acquisitions of shares in exchange for
Account assets transferred in-kind from
an Account, of an open-end investment
company (‘‘the Fund’’) registered under
the Investment Company Act of 1940
(the 1940 Act), other than an exchangetraded fund (an ‘‘ETF’’), the Investment
Adviser for which is also a fiduciary
with respect to the Account (or an
affiliate of such fiduciary) (hereinafter,
BGI and all its affiliates will be referred
to as ‘‘Investment Adviser’’), and the
receipt of fees for acting as an
investment adviser for such Funds, as
well as fees for providing other services
to the Funds which are ‘‘Secondary
Services,’’ as defined herein, in
connection with the investment by the
Accounts in shares of the Funds,
provided that the conditions set forth in
Section II are met.
Section II. Conditions
(a) The Account does not pay a sales
commission or other similar fees to the
Investment Adviser or its affiliates in
connection with such acquisition, sale,
or exchange.
(b) The Account does not pay a
redemption or similar fee to the
Investment Adviser in connection with
the sale by the Account to the Fund of
such shares, and the existence of any
other redemption fee is disclosed in the
Fund’s prospectus in effect at all times.
(c) The Account does not pay an
investment management, investment
advisory or similar fee with respect to
E:\FR\FM\10SEN1.SGM
10SEN1
]]>Agencies
[Federal Register Volume 72, Number 174 (Monday, September 10, 2007)]
[Notices]
[Pages 51665-51668]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-17757]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Randi M. Germaine, M.D.; Revocation of Registration
On December 14, 2006, the Deputy Assistant Administrator, Office of
Diversion Control, issued an Order to Show Cause to Randi M. Germaine,
M.D. (Respondent), of Casa Grande, Arizona. The Show Cause Order
proposed the revocation of Respondent's DEA Certificate of
Registration, BG3717278, as a practitioner, as well as the denial of
any pending applications for renewal or modification of the
registration, on the ground that his continued registration is
inconsistent with the public interest. Show Cause Order at 1.
The Show Cause Order specifically alleged that during the execution
of a search warrant at the Morenci Healthcare Center (Respondent's
former employer), copies of patient charts were obtained which were
then sent to a medical expert for review. Id. at 2. The Show Cause
Order alleged that the expert had concluded that Respondent's
``prescribing practices concerning controlled substances did not meet
the usual standard of care.'' Id. Relatedly, the Show Cause Order
alleged that background checks on some of Respondent's patients
indicated that they ``were receiving excessive and unnecessary amounts
of controlled substances,'' that they were known to law enforcement to
be ``drug abusers,'' and that some of them had committed controlled-
substance offenses. Id. Relatedly, the Show Cause Order alleged that
some of Respondent's patients ``were known to area pharmacists as
`doctor shoppers' and `chronic early refillers.' '' Id. Moreover, ``a
number of [Respondent's] patients were family members receiving the
same prescriptions for controlled substances.'' Id.
The Show Cause Order further alleged that the ``autopsy reports for
two of [Respondent's] patients * * * showed [that] the cause of death
[was] drug overdoses resulting from controlled substances prescribed
by'' Respondent. Id. The Show Cause Order also alleged that another of
Respondent's patients had ``died after obtaining invalid prescriptions
from [him] for controlled substances.'' Id.
On January 8, 2007, the Show Cause Order, which also notified
Respondent of his right to a hearing, was served on him as evidenced by
the signed return-receipt card. Because (1) More than thirty days have
passed since service of the Show Cause Order, and (2) Respondent did
not timely request a hearing, I conclude that Respondent has waived his
right to a hearing. See 21 CFR 1309.53(c). I therefore enter this Final
Order without a hearing based on relevant material found in the
investigative file and make the following findings.
Findings
Respondent is the holder of DEA Certificate of Registration,
BG3717278, which authorizes him to handle controlled substances as a
practitioner at the registered location of Harvest Medical Clinic,
Inc., 1856 E. Florence Blvd., Casa Grande, Arizona. Respondent's
registration does not expire until September 30, 2008.
On August 25, 2003, the Greenlee County Sheriff's Office contacted
the DEA Tucson Diversion Group regarding Respondent's termination from
the Morenci Healthcare Center based on the allegation that he over-
prescribed narcotic controlled substances. The Sheriff's Office also
informed DEA Investigators that R.S., a thirty-one year old male inmate
at the county jail and patient of Respondent, had died and that the
autopsy report had found both methadone and benzodiazepines in his
blood. While the autopsy report noted that the cause of death could not
be determined and that the ``[t]oxicology findings may be equivocal due
to decomposition,'' R.S. was known to local law enforcement as a drug
abuser. The Sheriff's Office further related that Respondent had
prescribed methadone (10 mg. tablets) for R.S. for back pain.
Subsequently, R.S.'s medical records were sent to Ted Parran, M.D.,
a board-certified internist and Associate Clinical Professor of
Medicine and Family Medicine at the Case Western Reserve University
School of Medicine and Director of its Addiction Fellowship
Programs.\1\ According to Dr. Parran's report (hereinafter, Expert
Report), R.S. died four days after Respondent started him on methadone
and ``had demonstrated much drug seeking behavior over the past two
years.'' Expert Report at 2. Dr. Parran noted that R.S. ``had [a]n MRI
scanning demonstrating little pathology, had longstanding complaints
and office behavior out of proportion to evidence of illness, and [a
history] of non-compliance with [physical therapy] referrals.'' Id. Dr.
Parran further noted that R.S. ``had been pretty much off of opioid
analgesics (except for a few Vicodin or Percocet) and in [j]ail for a
while when for some reason he was started on [m]ethadone * * * on 5/30/
02.'' Id. Dr. Parran concluded that ``[t]his prescribing is difficult
to imagine, fails to meet usual standards of care and concern when
prescribing controlled drugs, appears to be for other than [a]
legitimate medical purpose, and appears to have played a direct role in
the patient's death.'' Id.
---------------------------------------------------------------------------
\1\ Dr. Parran has also performed research and issued written
educational materials on addiction and controlled-substance
prescribing. He has also developed a remedial education course on
controlled-substance prescribing.
---------------------------------------------------------------------------
On or about May 31, 2003, D.K., a twenty-five year old female and
another of Respondent's patients, died of a drug overdose. According to
the toxicology report, hydrocodone, oxycodone, diazepam, and
nordiazepam were present in D.K.'s blood. Furthermore, the examining
pathologist found that
[[Page 51666]]
D.K.'s death ``is due to an acute intoxication due to the combined
effects of multiple prescription medications including hydrocodone and
oxycodone.''
Upon review of D.K.'s chart, Dr. Parran found ``much evidence of
out of control behavior.'' Expert Report at 5. More specifically, Dr.
Parran noted that D.K. had lied about her ``drug use''; that there was
``[c]lear evidence'' that on three occasions D.K. was ``Dr. shopping''
and that on four other occasions she engaged in ``scams'' to obtain
additional drugs; that her medical complaints bore ``no resemblance to
the physical exam''; that there were ``multiple multiple early refill
attempts''; and that approximately five months before her death,
another physician had diagnosed her with bipolar disorder and
determined that she ``need[ed] to be tapered off of all controlled
drugs.'' Id. at 5-6.
Dr. Parran also noted another visit in which Respondent had noted
that D.K. was ``worried about Hep[atitis] C and HIV * * * needle stick
exposure--sharing needles,'' and that she needed a urine drug screen.
Id. at 5. Dr. Parran observed that Respondent nonetheless issued D.K. a
prescription for Vicodin for ``acute pain and cough.'' Id.
Dr. Parran also found that D.K. had not been prescribed controlled
substances between January and May 9, 2003, the latter being the date
when Respondent ``began the prescribing that ultimately contributed to
[D.K.'s] death.'' Id. at 6. Dr. Parran noted that Respondent issued
prescriptions to D.K. on May 9, 2003 for 90 hydrocodone; on May 20,
2003, for another 90 hydrocodone; and on May 27, 2003, for 40 Percocet
(oxycodone).\2\ Id. On May 28, 2003, D.K. overdosed and died three days
later. Id. Based on his review, Dr. Parran concluded that Respondent's
prescribing of controlled substances ``fails to meet usual standards of
care, appears to be for other than legitimate medical purpose and
appears to have contributed directly to the patient's death.'' Id.
---------------------------------------------------------------------------
\2\ According to the investigative file, D.K.'s chart contained
a notation indicating that only her OB/GYN, who was treating her for
pain related to a minor surgical procedure, could prescribe
controlled substances to her. D.K.'s OB/GYN further told
investigators that there was no medical reason why D.K. should have
been prescribed controlled substances after April 30, 2003.
---------------------------------------------------------------------------
On July 31, 2003, S.B., a fifty-six year old female patient of
Respondent, also died of a drug overdose. The toxicology report noted
that propoxyphene, norproxyphene, and nordiazaepam were present in her
blood; the pathologist concluded that S.B.'s death was ``due to an
acute multidrug intoxication including * * * Propoxyphene.''
DEA investigators subsequently determined that between August 5,
2002, and July 21, 2003, Respondent prescribed for S.B. numerous
controlled substances. More specifically, he prescribed 5520
propoxyphene capsules, 1200 hydrocodone (7.5/500 mg.) tablets, 729
Oxycontin tablets in various strengths, 21 flurazepam (both 15 mg. and
30 mg. strength) tablets, 150 lorazepam (1 mg.) tablets, 90 oxycodone
(5 mg.) tablets, and 10 Duragesic (75 mcg.) patches.
Dr. Parran's review noted that S.B. ``was a longstanding patient of
the Health Center, with many medical problems including arthritis and
headaches, and with a warning note on the front of the chart * * * to
`avoid all narcotics.' '' Expert Report at 3. Dr. Parran further found
that ``from the first time [Respondent] saw this patient [he] began
adding controlled drugs'' including Vicodin, Darvocet, Fiorinal,
Tussionex, Oxycontin, Darvon, Ativan (lorazepam), and flurazepam. Id.
Dr. Parran further noted that Respondent had engaged in ``an
additional flurry of prescribing'' during the period of March and April
2003. Id. Specifically, he noted that Respondent prescribed Oxycontin
(40 mg.) on March 20th, Darvocet on April 1st, Vicodin on April 11th,
multiple strengths of Oxycontin on April 14th, Vicodin and Oxycontin
again on April 21st, and both flurazepam with two refills and a
Duragesic (fentanyl) patch on April 28th. Id. Dr. Parran further found
that ``in a six month period [Respondent] prescribed 3700 tablets of
opioids and additional benzodiazepines and barbiturates.'' Id. Dr.
Parran concluded that ``[t]his escalating prescribing of controlled
drugs to a drug seeking patient who was clearly out of control with her
use fails to meet usual standards of care, appears to be for other than
[a] legitimate medical purpose and appears to have contributed to the
patient's death.''\3\ Id.
---------------------------------------------------------------------------
\3\ Following the death of S.B., Respondent's former employer
reported Respondent to the Arizona Medical Board. The Board
subsequently concluded that Respondent had committed unprofessional
conduct under Ariz. Rev. Stat. Sec. 32-1401(27)(q). The Board
ordered that Respondent be issued a letter of reprimand for
excessive prescribing and be placed on probation. The Board's
decision focused entirely on Respondent's treatment of S.B. and did
not discuss his prescribing practices with respect to any other
patient. See In re Randi M. Germaine, M.D. (Ariz. Med. Bd. Aug. 12,
2005) (Case MD-03-0897A).
---------------------------------------------------------------------------
Dr. Parran also reviewed Respondent's prescribing with respect to a
fourth patient, N.G. Between October 31, 2002, and April 10, 2003,
Respondent prescribed for N.G., 1418 methadone (10 mg.) tablets, 605
oxycodone (5 mg.) tablets, and 120 hydrocodone (7.5/750 mg.) tablets.
According to Dr. Parran, this ``patient demonstrated Dr. shopping
behavior over a long period of time.'' Expert Report at 4. Moreover,
based on a December 12, 2002 toxicology screening, another physician at
the clinic had indicated that N.G. had violated her controlled-
substance contract. Id. Respondent nonetheless continued to prescribe
controlled substances to her. Id.
Dr. Parran further noted that N.G.'s chart indicated that she had
engaged in several scams to obtain additional controlled substances
including going to the emergency room, and claiming either that she had
run out early or that her drugs had been stolen. Id. Moreover,
notwithstanding that her chart included: (1) A pharmacy use printout
showing that N.G. was engaged in the ``tremendous over-use of
controlled drugs,'' (2) ``an extensive note'' from another physician
``indicating that she should get no more controlled drugs from the
practice,'' and (3) a March 2003 note from another clinic (that N.G.
had been referred to) which diagnosed her as a drug abuser and
recommended that she be ``wean[ed] off of narcotics,'' Respondent
continued to prescribe controlled substances to her. Id. Indeed, three
days after N.G. had again gone to the emergency room trying to get
early medications, Respondent again prescribed controlled substances to
her.\4\ Id. According to Dr. Parran, ``[t]his continued prescribing of
controlled drugs to a patient who was non-compliant with the treatment
plan and clearly out of control with her use fails to meet usual
standards of care and appears to be for other than [a] legitimate
medical purpose.'' Id.
---------------------------------------------------------------------------
\4\ Eventually another physician terminated N.G. from the
clinic's practice.
---------------------------------------------------------------------------
According to Dr. Parran, another of Respondent's patients (D.J.),
had ``demonstrated multiple behaviors that alerted the practice to her
problems with controlled drugs including early calls, early visits,
claiming [she was going] `out of town' for early scripts'' but ``then
keeping the original appointments.'' Id. at 7. Moreover,
notwithstanding that: (1) D.J. had broken her controlled substance
contract; (2) that another physician had recently indicated that D.J.
should no longer be prescribed controlled substances; and (3) that
Respondent had himself indicated that D.J.'s toxicology test results
were abnormal, that she was engaged in doctor shopping, and that
[[Page 51667]]
controlled drugs should be discontinued; two months later, Respondent
gave D.J. a prescription for Vicodin. Id. at 7-8. Respondent then
proceeded to issue D.J. numerous other prescriptions including several
early prescriptions and one based on her representation that she was
going out of town. Id. at 8. According to Dr. Parran, Respondent's
``continued prescribing of controlled drugs to a patient who was non-
compliant and clearly out of control with her use fails to meet usual
standards of care and appears to be for other than [a] legitimate
medical purpose.''' Id.
Discussion
Section 304(a) of the Controlled Substances Act provides that a
registration to ``dispense a controlled substance * * * may be
suspended or revoked by the Attorney General upon a finding that the
registrant * * * has committed such acts as would render his
registration under section 823 of this title inconsistent with the
public interest as determined under such section.'' 21 U.S.C.
824(a)(4). With respect to a practitioner, the Act requires the
consideration of the following factors in making the public interest
determination:
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The applicant's experience in dispensing * * * controlled
substances.
(3) The applicant's conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
Id.
``[T]hese factors are * * * considered in the disjunctive.'' Robert
A. Leslie, M.D., 68 FR 15227, 15230 (2003). I ``may rely on any one or
a combination of factors, and may give each factor the weight [I]
deem[] appropriate in determining whether a registration should be
revoked.'' Id. Moreover, case law establishes that I am ``not required
to make findings as to all of the factors.'' Hoxie v. DEA, 419 F.3d
477, 482 (6th Cir. 2005); see also Morall v. DEA, 412 F.3d 165, 173-74
(D.C. Cir. 2005).
In this matter, I acknowledge that the Arizona Medical Board has
not revoked Respondent's state license. The Board's inquiry was,
however, limited to Respondent's prescribing to a single patient.
Therefore, I decline to defer to the Board's decision and conclude that
Respondent's experience in dispensing controlled substances and his
record of non-compliance with Federal law and regulations demonstrate
that his continued registration is ``inconsistent with the public
interest.'' 21 U.S.C. 823(f).
Factors Two and Four--Respondent's Experience in Dispensing Controlled
Substances and Record of Compliance With Applicable Laws Relating to
Controlled Substances
Under DEA regulations, a prescription for a controlled substance is
not ``effective'' unless it is ``issued for a legitimate medical
purpose by an individual practitioner acting in the usual course of his
professional practice.'' 21 CFR 1306.04(a). This regulation further
provides that ``an order purporting to be a prescription issued not in
the usual course of professional treatment * * * is not a prescription
within the meaning and intent of [21 U.S.C. 829] and * * * the person
issuing it, shall be subject to the penalties provided for violations
of the provisions of law related to controlled substances.'' Id. As the
Supreme Court recently explained, ``the prescription requirement * * *
ensures patients use controlled substances under the supervision of a
doctor so as to prevent addiction and recreational abuse. As a
corollary, [it] also bars doctors from peddling to patients who crave
the drugs for those prohibited uses.'' Gonzales v. Oregon, 126 S.Ct.
904, 925 (2006) (citing Moore, 423 U.S. 122, 135 (1975)).
As found above, Dr. Parran, an expert on the prescribing of
controlled substances, reviewed the medical records of patients treated
by Respondent including several who had overdosed on controlled
substances. Dr. Parran specifically noted that Respondent prescribed
controlled substances to patients notwithstanding that they were
engaged in drug-seeking behaviors including doctor shopping and various
scams used to obtain additional prescriptions.
Moreover, Dr. Parran found in multiple instances that Respondent's
prescriptions were not issued for a legitimate medical purpose. With
respect to R.S., Dr. Parran found that Respondent's ``prescribing is
difficult to imagine, * * * appears to be for other than [a] legitimate
medical purpose, and appears to have played a direct role in the
patient's death.'' Expert Report at 2.
In regards to D.K., Dr. Parran noted that she too was engaged in
doctor shopping and other scams such as early refill attempts and
medical complaints that were not confirmed by a physical exam.
Moreover, her chart included a notation that only her OB/GYN could
prescribe controlled substances for her; her OB/GYN told investigators
that after April 30, 2003, there was no medical reason why she should
have been prescribed controlled substances. Nonetheless, on May 9 and
20, 2003, Respondent prescribed for D.K. drugs containing hydrocodone,
and on May 27, 2003, Respondent prescribed Percocet (oxycodone). D.K.
overdosed the next day. Based on his review, Dr. Parran concluded that
Respondent's prescribing of controlled substances for D.K. ``appears to
be for other than [a] legitimate medical purpose and appears to have
contributed directly to [her] death.'' Id. at 6.
S.B. was another patient of Respondent who died of an overdose.
With respect to her, Dr. Parran found that notwithstanding that her
chart included a warning note to ``avoid all narcotics,'' Respondent
prescribed controlled drugs including various opiates including
Vicodin, Darvocet, Tussionex, Oxycontin, and Darvon. In addition,
Respondent prescribed other controlled substances including
benzodiazepines and barbiturates. Dr. Parran further found that in a
six month period, Respondent prescribed 3,700 tablets of opioids (as
well as drugs in other categories of controlled substances). Dr. Parran
concluded that ``[t]his escalating prescribing of controlled drugs to a
drug seeking patient who was clearly out of control with her use * * *
appears to be for other than [a] legitimate medical purpose and appears
to have contributed to the patient's death.'' Id. at 3.
In sum, Dr. Parran's findings provide ample support for the
conclusion that Respondent was not issuing prescriptions for ``a
legitimate medical purpose,'' 21 CFR 1306.04(a), but rather, was
``peddling to patients who crave the drugs for * * * prohibited uses.''
Gonzales v. Oregon, 126 S.Ct. 904, 925 (2006) (citing Moore, 423 U.S.
122, 135 (1975)). Accordingly, I find that Respondent's experience in
dispensing controlled substances is characterized by repeated
violations of the CSA. I therefore conclude that Respondent's continued
registration is ``inconsistent with the public interest.'' 21 U.S.C.
823(f). Moreover, I further find that the public safety requires that
this Order be effective immediately. 21 CFR 1316.67.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) &
824(a), as well as 28 CFR 0.100(b) & 0.104, I hereby order that DEA
Certificate Registration, BG3717278, issued to Randi M.
[[Page 51668]]
Germaine, M.D., be, and it hereby is, revoked. I further order that any
pending applications for renewal or modification of his registration
be, and they hereby are, denied. This order is effective immediately.
Dated: August 30, 2007.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E7-17757 Filed 9-7-07; 8:45 am]
BILLING CODE 4410-09-P
